Drugs / Odevixibat
Regulatory milestones approvals, filings & regulatory actions · 4 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (2) | US (FDA) | BYLVAY | — | 2023-06-13 – 2025-12-19 | fda.gov ↗ |
| Approved | US (FDA) | BYLVAY | — | 2021-07-20 | fda.gov ↗ |
| Approved | EU (EMA) | Bylvay | — | 2021-07-16 | europa.eu ↗ |
Trials 11 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 13 trials | ||||||
| Phase 1 | NCT03608319 | Jul → Aug 2018 | — | Albireo | Completed | No outcome recorded |
| Phase 1 | NCT03082937 | Jan → Mar 2017 | Alagille syndrome, primary biliary cholangitis, progressive familial intrahepatic cholestasis | Albireo | Completed | No outcome recorded |
| Phase 1 | NCT02963077 | Jul 2013 → May 2014 | Alagille syndrome, primary biliary cholangitis, progressive familial intrahepatic cholestasis | Albireo | Completed | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT02360852 | Jan 2015 → Oct 2016 | primary biliary cholangitis | Sahlgrenska University Hospital | Terminated | No outcome recorded |
| Phase 36 trials | ||||||
| Phase 3 | NCT05426733 | Jul 2022 → Jun 2028 expected | biliary atresia | Albireo, an Ipsen Company | Enrolling by invitation | No outcome recorded |
| Phase 3 | NCT05035030 | Sep 2021 → Dec 2026 expected | Alagille syndrome | Albireo, an Ipsen Company | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04674761 | Mar 2021 → Sep 2022 | Alagille syndrome | Albireo | Completed | No outcome recorded |
| Phase 3 | NCT04336722 | Jul 2020 → Jun 2026 | biliary atresia | Albireo, an Ipsen Company | Completed | No outcome recorded |
| Phase 3 | NCT03659916 | Sep 2018 → Feb 2024 | progressive familial intrahepatic cholestasis | Albireo, an Ipsen Company | Completed | No outcome recorded |
| Phase 3 | NCT03566238 | May 2018 → Jul 2020 | progressive familial intrahepatic cholestasis type 1, progressive familial intrahepatic cholestasis type 2 | Albireo | Completed | No outcome recorded |
| Phase not stated1 trial | ||||||
| — | NCT04483531 | — | progressive familial intrahepatic cholestasis | Albireo | Approved for marketing | No outcome recorded |
Also used as a comparator or background therapy in 1 trial
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 2 | NCT02630875 Comparator | Aug 2015 → Mar 2017 | intrahepatic cholestasis | Albireo | Completed | No outcome recorded |
Press releases naming this drug 6 releases
| Date | Issuer | Release |
|---|---|---|
| 2025-09-19 | Ipsen | Bylvay® (odevixibat) approved in Japan for rare liver disease PFIC ipsen.com ↗ |
| 2024-11-18 | Ipsen | Bylvay® (odevixibat) data shows sustained improvement in severe itch and serum bile acid levels in patients with PFIC and ALGS ipsen.com ↗ |
| 2024-09-23 | Ipsen | Ipsen’s Kayfanda® (odevixibat) approved in European Union for cholestatic pruritus in Alagille Syndrome, a rare liver disease ipsen.com ↗ |
| 2024-07-26 | Ipsen | Ipsen receives CHMP positive opinions for Iqirvo® (elafibranor) in Primary Biliary Cholangitis and Kayfanda® (odevixibat) in Alagille Syndrome, two rare cholestatic liver diseases ipsen.com ↗ |
| 2023-10-23 | Ipsen | Ipsen updates on E.U. Marketing Authorisation Application for odevixibat in Alagille syndrome ipsen.com ↗ |
| 2023-05-17 | Ipsen | Ipsen to present new Bylvay® (odevixibat) data at annual ESPGHAN congress, showcasing commitment to furthering treatment for rare cholestatic liver diseases ipsen.com ↗ |
Evidence & citations 10 cited values
Every value below carries the sentence it was read from. 13 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | odevixibat | “A4250 (odevixibat)” NCT03566238 ↗ |
| Known as | A4250 | “Odevixibat (A4250)” NCT04336722 ↗ |
| Known as | AR-H064974 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297588 ↗ |
| Known as | AZD-8294 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297588 ↗ |
| Known as | IBAT Inhibitor A4250 | “IBAT Inhibitor A4250” NCT02360852 ↗ |
| Known as | Odevixibat (as sesquihydrate) | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297588 ↗ |
| Action | Inhibit | “Ileal bile acid transporter inhibitor” CHEMBL4297588 ↗1“IBAT Inhibitor A4250” NCT02360852 ↗ |
| Modality | Small molecule | “A4250 is a small molecule” NCT03566238 ↗ |
| Route | Oral | “1.5 - 3 mg orally” NCT02360852 ↗ |
| Target | SLC10A2 | “Ileal bile acid transporter inhibitor” CHEMBL4297588 ↗ |